Cleared Traditional

AART PECTORALIS IMPLANT

K021337 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery

Jul 2002

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K021337 is an FDA 510(k) clearance for the AART PECTORALIS IMPLANT, a Implant, Muscle, Pectoralis (Class II — Special Controls, product code MIC), submitted by Aesthetic and Reconstructive Technologies, Inc. (Paso Robles, US). The FDA issued a Cleared decision on July 3, 2002, 68 days after receiving the submission on April 26, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K021337 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2002
Decision Date	July 03, 2002
Days to Decision	68 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF